[Federal Register Volume 67, Number 25 (Wednesday, February 6, 2002)]
[Rules and Regulations]
[Pages 5470-5471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-2751]
[[Page 5470]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 530
[Docket No. 01N-0499]
Topical Nitrofurans; Extralabel Animal Drug Use; Order of
Prohibition
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (we) is issuing an order
prohibiting the extralabel use of topical nitrofuran animal and human
drugs in food-producing animals. We are issuing this order based on
evidence that extralabel use of topical nitrofuran drugs in food-
producing animals may result in the presence of residues that we have
determined to be carcinogenic and to not have been shown to be safe. We
find that such extralabel use ``presents a risk to the public health''
for the purposes of the Animal Medicinal Drug Use Clarification Act of
1994 (AMDUCA).
DATES: This rule is effective May 7, 2002. We invite your written or
electronic comments. We will consider all comments that we receive by
April 8, 2002.
ADDRESSES: Submit your written comments to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit electronic comments to http://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Gloria J. Dunnavan, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-1726,
e-mail: gdunnava@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. AMDUCA
AMDUCA (Public Law 103-396) was signed into law on October 22,
1994. It amended the Federal Food, Drug, and Cosmetic Act (the act) to
permit licensed veterinarians to prescribe extralabel uses of approved
animal and human drugs in animals. However, section 512(a)(4)(D) of the
act (21 U.S.C. 360b(a)(4)(D)) gives us authority to prohibit an
extralabel drug use in animals if, after affording an opportunity for
public comment, we find that such use presents a risk to the public
health.
We published the implementing regulations (codified at part 530 (21
CFR part 530)) for AMDUCA in the Federal Register of November 7, 1996
(61 FR 57732). The sections regarding prohibition of extralabel use of
drugs in food-producing animals are found at Secs. 530.21 and 530.25.
These sections describe the basis for issuing an order prohibiting an
extralabel drug use in food-producing animals and the procedure to be
followed in issuing an order of prohibition. We may issue a prohibition
order if we find that extralabel use in animals presents a risk to the
public health. Under Sec. 530.3(e), this means that we have evidence
that demonstrates that the use of the drug has caused or likely will
cause an adverse event.
Section 530.25 provides for a public comment period of not less
than 60 days. It also provides that the order of prohibition will
become effective 90 days after the date of publication, unless we
revoke the order, modify it, or extend the period of public comment.
The list of drugs prohibited from extralabel use is found in
Sec. 530.41. The current list of drugs prohibited from extralabel use
in food-producing animals includes furazolidone and nitrofurazone, but
it contains the parenthetical statement ``(except for approved topical
use)''.
II. Nitrofurans
In 1991, and after a full evidentiary hearing, we withdrew the
approvals for furazolidone and nitrofuranzone labeled for antiprotozoal
use in a wide variety of conditions in poultry and swine. (See the
Federal Register of August 23, 1991 (56 FR 41902).) These withdrawals
were based on our determination that use of the drugs resulted in
residues in edible tissues for human food and that residues of these
drugs were not shown to be safe, in part because both drugs are
carcinogenic. We did not, however, withdraw the approvals of these
products for use in nonfood animals or for topical use in food-
producing animals. Moreover, while our current regulations in
Sec. 530.41 prohibit extralabel use of approved furazolidone and
nitrofurazone products in food-producing animals, this prohibition does
not extend to topical use in food-producing animals. These topical uses
in food-producing animals were allowed because there was no evidence
that such use of furazolidone and nitrofuranzone resulted in residues
in edible tissues.
However, a recent carbon-14 (C-14) radio-label residue depletion
study that we conducted showed that detectable levels of nitrofuran
derivatives are present in edible tissues (milk, meat, kidney, liver)
of cattle treated by the ocular (eye) route (Ref. 1). This study,
coupled with our findings in our prior withdrawal action, means that
residues, which are carcinogenic and have not been shown to be safe,
will likely be present at slaughter as a result of topical uses of
nitrofurans, including furazolidone and nitrofurazone, in food-
producing animals.
We advised all manufacturers of nitrofuran drugs that were approved
for ocular use in food-producing animals of the evidence and the
manufacturers revised their labels to remove those indications. (See,
for example, 65 FR 41587 (July 6, 2000).) Some lot numbers of these
drugs may remain in commercial distribution channels with the former
labels that contain indications for food-producing animals. These
products, however, are not approved for use in food-producing animals
and, therefore, are adulterated and misbranded. Some topical and
ophthalmic nitrofuran products are still approved for certain uses in
nonfood animals. Under the current regulations governing extralabel
use, these remaining approved topical and ophthalmic products are not
prohibited from extralabel topical use in food-producing animals.
However, as stated previously, there is evidence that these uses will
result in residues in edible tissues. Because of the likelihood of this
adverse event, by this order of prohibition, we are prohibiting all
extralabel uses, including extralabel topical use, in food-producing
animals of nitrofuran products that are approved for use in nonfood
animals or humans. Therefore, no nitrofuran product may be legally used
in food-producing animals.
III. Request for Comments
We are providing 60 days from the date of this publication for you
to comment. The order will become effective May 7, 2002, unless we
revoke or modify the order or extend the comment period. You may submit
written or electronic comments to the Dockets Management Branch
(address above) by April 8, 2002. Please identify your comments with
the docket number found in brackets in the heading of this document.
You may read any comments that we receive at our Dockets Management
Branch reading room (address above). The reading room is open from 9
a.m. to 4 p.m., Monday through Friday, except for Federal holidays.
IV. Order of Prohibition
Therefore, I hereby issue the following order under section
512(a)(4)(D) of the act and 21 CFR 530.21 and 530.25. We find that
extralabel use of nitrofurans in food-
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producing animals likely will cause an adverse event, which constitutes
a finding under section 512(a)(4)(D) of the act that extralabel use of
these drugs in food-producing animals presents a risk to the public
health. Therefore, we are prohibiting all extralabel uses of these
drugs in food-producing animals.
V. Reference
The following information has been placed on display in the Dockets
Management Branch (address above). You may view it between 9 a.m. and 4
p.m., Monday through Friday.
1. Smith, D. J., G. D. Paulson, and G. L. Larsen, ``Distribution
of Radiocarbon After Intermammary, Intrauterine or Ocular Treatment
of Lactating Cows With Carbon-14 Nitrofurazone,'' Journal of Dairy
Science, vol. 81, pp. 979-988, 1998.
List of Subjects in 21 CFR Part 530
Administrative practice and procedure, Advertising, Animal drugs,
Labeling, Reporting and recordkeeping requirements.
Accordingly, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director of the Center for Veterinary Medicine, 21
CFR part 530 is amended as follows:
PART 530--EXTRALABEL DRUG USE IN ANIMALS
1. The authority citation for 21 CFR part 530 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351,
352, 353, 355, 357, 360b, 371, 379e.
Sec. 530.41 [Amended]
2. Section 530.41 Drugs prohibited for extralabel use in animals is
amended in paragraphs (a)(7) and (a)(8) by removing the parenthetical
phrase ``(except for approved topical use)''.
Dated: November 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-2751 Filed 2-5-02; 8:45 am]
BILLING CODE 4160-01-S